medical device training

Cleanroom and Associate Controlled Environment

Participants will be introduced to the principles and methodology of air cleanliness classification in cleanrooms, the prerequisite and optional tests, changing room best practices with reference to the standard, implementation of the standard’s specified requirements during operation and an understanding of biocontamination, principals for its control and monitoring.
Read MoreCleanroom and Associate Controlled Environment

Design of Experiment

Design of Experiments (DOE) is a systematic experimentation method. It is more efficient that the traditional experimentation methods such as the One-Factor-At-A-Time (OFAT) and Best Educated Guess. DOE employs statistic to model and optimize a process. It is widely used in process validation, parameter settings and developing a robust process
Read MoreDesign of Experiment

Good Distribution Practice for Medical Devices (GDPMD) Internal Audit

This course is designed for those with a working knowledge of medical device distribution practices and starts with a review of MDA/RR No.1. Participants will gain a broad understanding of Good Distribution Practice for Medical Devices (GDPMD) requirements together with associated regulatory requirements and guidance documents as well as internal audit methodology.
Read MoreGood Distribution Practice for Medical Devices (GDPMD) Internal Audit

Medical Device Manufacturing Process Validation

This course provides regulatory/quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA’s Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program.
Read MoreMedical Device Manufacturing Process Validation